The team at Marinus Pharmaceuticals Inc. will be digging into results from the missed phase III study in drug-resistant focal onset seizures, hoping to determine why ganaxolone failed to mirror the reduction in seizure rate observed in earlier trials. Read More
Galena Biopharma Inc., of San Ramon, Calif., said that five phase I trials in healthy volunteers and one phase II single arm, open label pilot study in patients with myeloproliferative neoplasms (MPN) found that GALE-401, its controlled release version of anagrelide, is well tolerated. Read More
Merck & Co. Inc., of Kenilworth, N.J., announced results from two phase III studies evaluating MK-1293, Merck's investigational, follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes. Read More
A year after its founding, Alpine Immune Sciences Inc. (AIS) sped to a $48 million series A round that was led by Orbimed Advisors and joined by Frazier Healthcare Partners and Alpine Bioventures. In January 2015, Alpine Bio founded and provided the seed funding for Seattle-based AIS, which is developing protein-based immunotherapies using its variant immunoglobulin domain, or vIgD, platform technology, to interact simultaneously with multiple targets in the immune synapse using a single molecule. Read More
The Supreme Court has yet again repudiated the Federal Circuit in a patent law decision, this time in a case testing the lower court's perspectives on infringement and enhanced damages. The high court, minus Antonin Scalia, turned around an 8-0 decision trashing the Federal Circuit's two-part test for willful infringement, leaving the determination of whether to award enhanced damages to the discretion of district courts. Read More
Paxvax Inc. has gained FDA approval for Vaxchora, the only cholera vaccine to be approved in the U.S. The approval comes with a valuable tropical disease priority review voucher that CEO Nima Farzan told BioWorld Today the company is likely to sell. Read More
DUBLIN – Fourteen exits in the last three years enabled Gilde Healthcare to close out rapidly its fourth fund, Gilde Healthcare IV, at €250 million (US$282 million). That mark represented its hard cap or upper limit – it had sought €200 million initially. Read More
HONG KONG – Aiming to address a perceived disparity in the quality of manufacturing of drugs for the China market, the CFDA is ramping up its focus on offshore drug manufacturers. The regulator last year stepped up the number of overseas good manufacturing practice (GMP) inspections it carried out, while domestically, it put more of the onus on companies to police themselves. Read More
The U.S. Department of Health and Human Services signed a memorandum of understanding Monday with Cuba's Ministry of Public Health. The agreement establishes coordination on a number of public health issues, including global health security, communicable and noncommunicable diseases, R&D and information technology. Read More
Nexus Biopharma Inc., of Montclair, N.J., formerly Plata Resources Inc., said it completed its merger with Nexus Biopharma Inc., a company developing an obesity drug targeting the AMPK metabolic pathway. As a publicly operating company, the life sciences firm said its access to capital markets will enable it to complete drug optimization and pre-investigational new drug application studies to move toward clinical testing. Read More
